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An open trial evaluation of the BDZ (information and reduction) digital health program for people using benzodiazepines.

A pre-, post-intervention and 3- and 6-month follow up open trial evaluation of the BDZ digital health program, offered through the My Digital Health platform, to assist in reducing benzodiazepine usage and anxiety and depressive symptoms for Australian adults using benzodiazepines.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000574347
Enrollment
49
Registered
2017-04-24
Start date
2017-08-06
Completion date
2021-09-30
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

An open trial will be used to evaluate the effectiveness of the benzodiazepine digital health program (BDZ digital health) that provides psycho-education and gradual reduction information. BDZ digital health can be accessed on multiple devices (desk top, tablet and mobile). People, who visit the website, either directly or through seeing the study advertised, will be invited to take part in the BDZ digital health evaluation study. BDZ digital health is designed to provide people with information and strategies to address their benzodiazepine use via five ‘core’ modules, plus an Introduction module. Each module will take approximately 20 minutes to complete. Participants will receive automated emails (e.g., when to complete the during, post/follow-up intervention questionnaires). During the course of the study we strongly encourage participants to work with their doctor should they decide to reduce their benzodiazepine dosage as well as seek specialist benzodiazepine telephone support from Reconnexion. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 3) assessments, a post-intervention assessment (Week 6) and a 3 and 6 month follow-up scheduled assessment (Week 18 & Week 30 respectively). Participants will continue to have access to the program until Week 38 (8 weeks following the 6 month assessment). Participants will be asked questions to ascertain reasons for engagement or lack of engagement with the program. It is expected that people who undertake BDZ digital health will show reductions in their benzodiazepine dependency, anxiety and / or depressive symptoms at post and 3 and 6 month follow-up time points.

Interventions

An open trial (pre-intervention through to a 6-month follow-up assessment) will be used to evaluate the effectiveness of the benzodiazepine digital health program (BDZ digital health) that provides psycho-education and gradual reduction information. BDZ digital health is designed to provide people with information and strategies to address their benzodiazepine use via five ‘core’ modules, plus an Introduction module. The five BDZ digital health core modules are: 1. Benzodiazepines and Depende

An open trial (pre-intervention through to a 6-month follow-up assessment) will be used to evaluate the effectiveness of the benzodiazepine digital health program (BDZ digital health) that provides psycho-education and gradual reduction information. BDZ digital health is designed to provide people with information and strategies to address their benzodiazepine use via five ‘core’ modules, plus an Introduction module. The five BDZ digital health core modules are: 1. Benzodiazepines and Dependence: This module provides psycho-education around what BDZs are, dependency on BDZ, BDZ effectiveness and appropriate and inappropriate uses of BDZ. 2. The Pathway to Reduction: This module provides psycho-education on BDZ reduction and withdrawal processes, involving the 3 main steps in the BDZ reduction process 3. A Gradual Reduction Program (Case Illustration). This third module provides an illustrative case example of ‘Peter’ outlining his gradual benzodiazepine reduction program over time. 4. Withdrawal Symptoms. This module provides information around what BDZ related withdrawal symptoms are, common and uncommon withdrawal symptoms, and the issues with going ‘cold turkey’. 5. Managing Withdrawal Symptoms: This module contains information and helpful strategies to help manage the reduction/withdrawal symptoms (e.g., controlled breathing, progressive muscle relaxation, mindfulness meditation, problem solving, goal setting, increasing physical exercise, nutrition, sleep hygiene). All modules are open from the first log in and each module will take approximately 20 minutes to complete. Participants are encouraged to first read the Introduction module and then work through the other modules at their own pace, over the five weeks. Given the open access nature of the program modules, participants are free to choose whether they work through the modules sequentially or not. Participants will receive automated emails (e.g., to log on, when to complete the ‘during’, post intervention and follow-up scheduled assessment questionnaires). Modules make use of text, graphics, audio, video, editable forms, interactive games and downloads. Modules can be accessible via web, mobile or tablet devices. We also encourage participants to make use of the Reconnexion Benzodiazepine telephone support service while undertaking the BDZ digital health program, as well as work in conjunction with their doctor should they wish to commence benzodiazepine reduction. The BDZ digital health program is housed within the participant's ‘My Digital Health’ dashboard. My Digital Health is the parent platform that houses a variety of digital health programs. Via the participant’s dashboard, they are able to access several resources. This includes: My Dashboard, My Inbox, My Daily Monitoring, My Progress Graphs, My Timeline, My Profile and My Tutorial. It also includes a ‘Connect to Practitioner’ request button. If clicked, an Australian-based participant can request that we add their healthcare practitioner to their My Digital Health account. If the healthcare practitioner consents to participate, the healthcare practitioner is then digitally connected to the participant’s My Digital Health account. Participants will complete a pre-intervention assessment (Week 0), ‘during’ intervention (Week 3) assessment, a post-intervention assessment (Week 6) and a 3 and 6-month follow-up assessment (Week 18 & Week 30 respectively). While the ‘during’, post-intervention and follow up assessments are scheduled, participants will not be able to access the BDZ digital health program until they have completed the scheduled assessments (or after the expiry time to complete the scheduled assessment has lapsed). Participants will retain access to the program until Week 38 (8 weeks past the 6-month follow-up assessment). Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages / modules they visited / used and when), as well as reviewing the module review questions submitted, completion of daily mood and lifestyle event survey and scheduled intervention assessments. Participating healthcare practitioners may be invited to provide feedback about their digital connection experience.

Sponsors

Federation University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants must be 18 years or older, currently using benzodiazepines, have access to the internet, provide consent, and be able to register online using an email address.

Exclusion criteria

Participants must not be residing overseas, do not have a current untreated and severe (psychotic) illness, nor will they be using the ‘cold turkey’ method to reduce their benzodiazepine intake during the study (i.e., complete withdrawal from their benzodiazepines).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 8, 2026